Obesity
Conditions
Keywords
Healthy lifestyle Intervention, Serious Mental Illness, Effectiveness trial, Supportive housing, Racial and Ethnic Health Disparities
Brief summary
This goal of this randomized controlled effectiveness trial is to compare the effectiveness of a peer-led health lifestyle intervention (Peer GLB) versus usual care services in supportive housing agencies in New York City and Philadelphia serving diverse clients with serious mental illness who are overweight or obese. The intervention follows the Group Lifestyle Balance curriculum derived from the Diabetes Prevention Program and that has been shown to help people achieve clinically significant weight loss (equal to or greater than 5% weight loss of initial weight). The intervention will be delivered by trained peer-specialists employed at the supportive housing agencies and supervised by the study team. Peer GLB is a 12-month group intervention that focuses helping people lose weight by improving people's diet and increasing their physical activity and consists of weekly core group sessions (3 mo.), bi-monthly transitional group sessions (3 mo.), and maintenance monthly sessions (6 mo.). We plan to enroll 300 clients with serious mental illness who are overweight/obese (BMI equal to or greater than 25) from our two supportive housing agencies. Clients will be randomized to either the Peer-led healthy lifestyle intervention or usual care conditions. The primary outcome for this study is achieving clinically significant weight loss (equal to or greater than 5% weight loss from baseline weight) at 12 and 18 months post randomization. The secondary outcomes for this study include overall reductions in weight, waist circumference, blood pressure, and improvements in physical activity, self-efficacy, recovery and health-related quality of life. Repeated assessments will be at baseline, 6, 12 and 18 month post randomization. Primary Hypothesis: Peer GLB participants will have a higher proportion of persons achieving clinically significant weight loss (equal to or greater than 5% weight loss) at 12 and 18 months than UC participants. Secondary Hypothesis: At 6, 12, and 18 months post-randomization, there will be significant reductions in average weight, waist circumference, blood pressure, and significant improvements in physical activity, self-efficacy, recovery, and health-related quality of life in Peer GLB compared to UC.
Interventions
BEHAVIORALPeer-Led Group Lifestyle Balance
The intervention follows the Group Lifestyle Balance curriculum derived from the Diabetes Prevention Program and The intervention will be delivered by trained peer-specialists employed at the supportive housing agencies and supervised by the study team. Peer GLB is a 12-month group intervention that focuses helping people lose weight by improving people's diet and increasing their physical activity and consists of weekly core group sessions (3 mo.), bi-monthly transitional group sessions (3 mo.), and maintenance monthly sessions (6 mo.).
BEHAVIORALUsual Care Services
The usual care condition encompasses the regular services offered at supportive housing agencies to help clients with their physical health and wellness.
Sponsors
National Institute of Mental Health (NIMH)
Washington University School of Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Male or female,18 years of age or older, of any race/ethnicity, who are English and/or Spanish speakers. * Chart diagnosis of a serious mental illness (SMI; e.g., schizophrenia, bipolar disorder, schizoaffective disorders, major depression). * Overweight/obese as determined by a Body Mass Index (BMI) equal to or greater than 25 (kg/m2) at the time of recruitment. * Able and willing to give informed consent and participate in the intervention. * Received a medical clearance from a primary care or medical provider to participate in light-to-moderate physical activity (e.g., 150 minutes a week of brisk walking).
Exclusion criteria
* Need for detoxification services at the time of recruitment. * Pose a danger to self or others at the time of recruitment. * Have medical conditions that contraindicate their participation in a healthy lifestyle program focusing on weight loss and physical activity, such as active cancer treatment, liver failure, history of anorexia nervosa, cardiovascular event \[e.g., unstable angina, myocardial infraction\] within the past 6 months, untreated exercise- induced asthma, walking limitations preventing participation in exercise, and pregnant or planning a pregnancy during study period. * Fail a capacity-to-consent questionnaire. * Cognitive impairment as detected by the Mini-Cog Examination
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinically Significant Weight Loss | Baseline to 18 Months | Percentage of participants that achieve equal to or greater than 5% weight loss in lb from baseline at 12 and 18th months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall Reduction in Waist Circumference Measures to the Nearest cm From Baseline to 6, 12 and 18 Months | At study endpoint (18 months). | Waist circumference measured by a trained research assistant to the nearest 0.1 cm with an anthropometric tape, in a horizontal plane 1 cm above the navel in light indoor clothing. |
| Overall Reductions in Systolic Blood Pressure From Baseline, 6, 12 and 18 Months | At study endpoint (18 months). | Blood pressure assessed on the right arm of participants after they rest quietly in a seated position for at least 5 minutes, using a validated automated sphygmomanometer. |
| Self-Efficacy for Exercise | At study endpoint (18 months). | Self-efficacy for exercise was measured with a three-item scale assessing a person's confidence that they can engage in physical activity. The scores from this scale range from 1 to 10 with higher scores indicating higher self-efficacy. |
| Overall Reduction in Weight in lb From Baseline to 6, 12 and 18 Months | At study endpoint (18 months). | Weight (in pounds) was measured by a trained research assistant with a calibrated digital scale (participants wore indoor clothing without shoes). |
| Health-related Quality of Life | At study endpoint (18-months). | The 12-Item Short-Form Health Survey (SF-12) was used to capture participants health-related quality of life. The Physical Composite Score derived from the SF-12 is an indicator of health-related quality of life with scores that range from 0 to 100 with higher scores indicating higher health-related quality of life. |
| 6-Minutes Walking Test | At study endpoint (18-months). | The 6-minutes Walking Test is an objective measure of functional exercise capacity that captures the distance (in meters) that participants walk at a normal pace along a flat and straight course for 6 minutes. |
| Change From Baseline in Recovery Using the Recovery Assessment Scale (RAS). | At study endpoint (18 months). | The Recovery Assessment Scale is a 24-item measure that captures different aspects of recovery and produces a total recovery score ranging from 1 to 5 with higher scores indicating higher recovery. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Peer-led Group Lifestyle Balance Group-based behavioral healthy lifestyle program
Peer-Led Group Lifestyle Balance: The intervention follows the Group Lifestyle Balance curriculum derived from the Diabetes Prevention Program and The intervention will be delivered by trained peer-specialists employed at the supportive housing agencies and supervised by the study team. Peer GLB is a 12-month group intervention that focuses helping people lose weight by improving people's diet and increasing their physical activity and consists of weekly core group sessions (3 mo.), bi-monthly transitional group sessions (3 mo.), and maintenance monthly sessions (6 mo.).
Usual Care Services: The usual care condition encompasses the regular services offered at supportive housing agencies to help clients with their physical health and wellness. | 157 |
| Usual Care Services Usual wellness and health care services offered to clients at the two supportive housing agencies.
Usual Care Services: The usual care condition encompasses the regular services offered at supportive housing agencies to help clients with their physical health and wellness. | 157 |
| Total | 314 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Death | 3 | 4 |
| Overall Study | Developed Contraindicated Condition | 8 | 0 |
| Overall Study | Discharged from Supportive Housing Agenc | 13 | 15 |
| Overall Study | Lost to Follow-up | 4 | 4 |
| Overall Study | Withdrawal by Subject | 7 | 4 |
Baseline characteristics
| Characteristic | Total | Usual Care Services | Peer-led Group Lifestyle Balance |
|---|---|---|---|
| Age, Continuous | 48.65 years STANDARD_DEVIATION 11.56 | 48.81 years STANDARD_DEVIATION 11.6 | 48.50 years STANDARD_DEVIATION 11.56 |
| Race/Ethnicity, Customized Hispanic | 39 Participants | 26 Participants | 13 Participants |
| Race/Ethnicity, Customized Non-Hispanic Black | 181 Participants | 77 Participants | 104 Participants |
| Race/Ethnicity, Customized Non-Hispanic White | 57 Participants | 29 Participants | 28 Participants |
| Race/Ethnicity, Customized Other | 37 Participants | 25 Participants | 12 Participants |
| Sex: Female, Male Female | 133 Participants | 66 Participants | 67 Participants |
| Sex: Female, Male Male | 181 Participants | 91 Participants | 90 Participants |
| Weight | 218.79 Pounds STANDARD_DEVIATION 54.01 | 211.84 Pounds STANDARD_DEVIATION 48.83 | 225.75 Pounds STANDARD_DEVIATION 58.07 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 3 / 157 | 4 / 157 |
| other Total, other adverse events | 0 / 157 | 0 / 157 |
| serious Total, serious adverse events | 21 / 157 | 21 / 157 |
Outcome results
Primary
Clinically Significant Weight Loss
Percentage of participants that achieve equal to or greater than 5% weight loss in lb from baseline at 12 and 18th months
Time frame: Baseline to 18 Months
Population: Participants enrolled in the trial and randomized to either Peer-led Group Lifestyle Balance or Usual Care Services
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Peer-led Group Lifestyle Balance | Clinically Significant Weight Loss | 39 Participants |
| Usual Care Services | Clinically Significant Weight Loss | 40 Participants |
p-value: >0.0595% CI: [0.62, 1.84]Regression, Logistic
Secondary
6-Minutes Walking Test
The 6-minutes Walking Test is an objective measure of functional exercise capacity that captures the distance (in meters) that participants walk at a normal pace along a flat and straight course for 6 minutes.
Time frame: At study endpoint (18-months).
Population: Participants enrolled in the trial and randomized to either Peer-led Group Lifestyle Balance or Usual Care Services.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Peer-led Group Lifestyle Balance | 6-Minutes Walking Test | 315.83 meters | Standard Error 95.97 |
| Usual Care Services | 6-Minutes Walking Test | 318.16 meters | Standard Error 93.38 |
p-value: 0.24Mixed Models Analysis
Secondary
Change From Baseline in Recovery Using the Recovery Assessment Scale (RAS).
The Recovery Assessment Scale is a 24-item measure that captures different aspects of recovery and produces a total recovery score ranging from 1 to 5 with higher scores indicating higher recovery.
Time frame: At study endpoint (18 months).
Population: Participants enrolled in the trial and randomized to either Peer-led Group Lifestyle Balance or Usual Care Services.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Peer-led Group Lifestyle Balance | Change From Baseline in Recovery Using the Recovery Assessment Scale (RAS). | 4.26 score on a scale | Standard Deviation 0.64 |
| Usual Care Services | Change From Baseline in Recovery Using the Recovery Assessment Scale (RAS). | 4.26 score on a scale | Standard Deviation 0.57 |
p-value: 0.39Mixed Models Analysis
Secondary
Health-related Quality of Life
The 12-Item Short-Form Health Survey (SF-12) was used to capture participants health-related quality of life. The Physical Composite Score derived from the SF-12 is an indicator of health-related quality of life with scores that range from 0 to 100 with higher scores indicating higher health-related quality of life.
Time frame: At study endpoint (18-months).
Population: Participants enrolled in the trial and randomized to either Peer-led Group Lifestyle Balance or Usual Care Services.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Peer-led Group Lifestyle Balance | Health-related Quality of Life | 44.81 score on a scale | Standard Deviation 10.36 |
| Usual Care Services | Health-related Quality of Life | 45.71 score on a scale | Standard Deviation 10.26 |
p-value: 0.52Mixed Models Analysis
Secondary
Overall Reduction in Waist Circumference Measures to the Nearest cm From Baseline to 6, 12 and 18 Months
Waist circumference measured by a trained research assistant to the nearest 0.1 cm with an anthropometric tape, in a horizontal plane 1 cm above the navel in light indoor clothing.
Time frame: At study endpoint (18 months).
Population: Participants enrolled in the trial and randomized to either Peer-led Group Lifestyle Balance or Usual Care Services.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Peer-led Group Lifestyle Balance | Overall Reduction in Waist Circumference Measures to the Nearest cm From Baseline to 6, 12 and 18 Months | 114.61 centimeters (CM) | Standard Deviation 18.84 |
| Usual Care Services | Overall Reduction in Waist Circumference Measures to the Nearest cm From Baseline to 6, 12 and 18 Months | 110.38 centimeters (CM) | Standard Deviation 16.91 |
p-value: 0.91Mixed Models Analysis
Secondary
Overall Reduction in Weight in lb From Baseline to 6, 12 and 18 Months
Weight (in pounds) was measured by a trained research assistant with a calibrated digital scale (participants wore indoor clothing without shoes).
Time frame: At study endpoint (18 months).
Population: Participants enrolled in the trial and randomized to either Peer-led Group Lifestyle Balance or Usual Care Services. Results presented are weight at the study endpoint (18-months).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Peer-led Group Lifestyle Balance | Overall Reduction in Weight in lb From Baseline to 6, 12 and 18 Months | 226.04 lb | Standard Deviation 62.81 |
| Usual Care Services | Overall Reduction in Weight in lb From Baseline to 6, 12 and 18 Months | 209.51 lb | Standard Deviation 50.41 |
p-value: 0.804Mixed Models Analysis
Secondary
Overall Reductions in Systolic Blood Pressure From Baseline, 6, 12 and 18 Months
Blood pressure assessed on the right arm of participants after they rest quietly in a seated position for at least 5 minutes, using a validated automated sphygmomanometer.
Time frame: At study endpoint (18 months).
Population: Participants enrolled in the trial and randomized to either Peer-led Group Lifestyle Balance or Usual Care Services.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Peer-led Group Lifestyle Balance | Overall Reductions in Systolic Blood Pressure From Baseline, 6, 12 and 18 Months | 129.52 Millimeters of mercury (mmHg) | Standard Deviation 17.7 |
| Usual Care Services | Overall Reductions in Systolic Blood Pressure From Baseline, 6, 12 and 18 Months | 128.28 Millimeters of mercury (mmHg) | Standard Deviation 19.13 |
p-value: 0.64Mixed Models Analysis
Secondary
Self-Efficacy for Exercise
Self-efficacy for exercise was measured with a three-item scale assessing a person's confidence that they can engage in physical activity. The scores from this scale range from 1 to 10 with higher scores indicating higher self-efficacy.
Time frame: At study endpoint (18 months).
Population: Participants enrolled in the trial and randomized to either Peer-led Group Lifestyle Balance or Usual Care Services.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Peer-led Group Lifestyle Balance | Self-Efficacy for Exercise | 6.73 Score on a scale | Standard Deviation 2.58 |
| Usual Care Services | Self-Efficacy for Exercise | 6.89 Score on a scale | Standard Deviation 2.32 |
p-value: 0.38Mixed Models Analysis